Argyle 8888160440

GUDID 10884527020546

PVC Umbilical Catheter Tray

Cardinal Health, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884527020546
• NIH Device Record Key: b55f1a1d-2c5a-4874-ad77-fc7e427c840e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Argyle
• Version Model Number: 8888160440
• Catalog Number: 8888160440
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French
• Catheter Gauge: 3.5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884527020546 [Package]; Contains: 20884527020543; Package: CASE [5 Units]; In Commercial Distribution
GS1	20884527020543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942564

FDA Product Code

• FOS: CATHETER, UMBILICAL ARTERY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 10
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Argyle]

• 00884521074067: Flexible Yankauer,Large Tip, No Vacuum Control
• 20884521101774: Poole Suction Instrument,Rigid
• 00884521139360: Aortic Perfusion Cannula,Angled Tip
• 00884521139377: Aortic Perfusion Cannula,Angled Tip
• 00884521139384: Aortic Perfusion Cannula,Straight Tip
• 00884521139391: Aortic Perfusion Cannula,Straight Tip
• 00884521139353: Aortic Perfusion Cannula,Angled Tip
• 00884521063238: Aortic Perfusion Cannula,Angled Tip
• 00884521063221: Aortic Perfusion Cannula,Angled Tip
• 00884521063214: Aortic Perfusion Cannula,Angled Tip
• 00884521060886: Thoracic Catheter,Straight
• 00884521060879: Thoracic Catheter,Straight
• 00884521060862: Thoracic Catheter,Straight
• 00884521060855: Thoracic Catheter,Straight
• 00884521060848: Thoracic Catheter,Straight
• 00884521060831: Thoracic Catheter,Straight
• 00884521060824: Thoracic Catheter,Straight
• 00884521060817: Thoracic Catheter,Straight
• 00884521149277: Penrose Tubing Radiopaque
• 00884521067533: Penrose Tubing Radiopaque
• 00884521067526: Penrose Tubing Radiopaque
• 20884521067513: Penrose Tubing Radiopaque
• 00884521067496: Penrose Tubing Radiopaque
• 00884521067489: Penrose Tubing Radiopaque
• 00884521067472: Penrose Tubing Radiopaque
• 00884521149147: Penrose Tubing Radiopaque
• 20884521067452: Penrose Tubing Radiopaque
• 00884521149123: Penrose Tubing Radiopaque
• 20884521067438: Penrose Tubing Radiopaque
• 10884521067424: Penrose Tubing Radiopaque
• 00884521071356: Penrose Tubing Radiopaque
• 00884521067403: Penrose Tubing Radiopaque
• 00884521073312: Gentle Flow Suction Catheter,Vacuum Control
• 00884521142001: Left Ventricular Catheter,Ferguson, Radiopaque Line and Eye
• 00884521061036: Carotid Artery Shunt Kit,Radiopaque Line, Straight
• 00884521088187: Female Luer Adapter
• 00884521115913: One Bottle Drainage System,9/32 inch (0.7 cm) Tubing
• 00884521074074: Flexible Yankauer,Fine Tip, No Vacuum Control
• 00884521074050: Flexible Yankauer,Medium Sump Tip, Vacuum Control
• 00884521074029: Flexible Yankauer,Medium Tip, No Vacuum Control
• 00884521061043: Vascular Tourniquet Kit
• 00884521071899: Saratoga Sump Drain
• 00884521071882: Saratoga Sump Drain
• 00884521071875: Saratoga Sump Drain
• 20884527001863: Graduated Suction Catheter Tray with Chimney Valve,Sterile Water
• 10884521002999: Surgical Aspirator Tip,Regular Opening, Opaque
• 10884527020041: Hydrogel Adhesive Baby Tape Strips
• 20884527004635: Infant Heel Warmer,Attachment Tab
• 20884527004628: Infant Heel Warmer,No Attachment Tab
• 10884527000197: Suction Catheter with Mucus Trap,20 mL